The Study Evaluates the Effect of an Interactive Projector as a Distraction for Children During Anesthetic Induction. The Primary Objective is to Reduce Perioperative Anxiety, Measured With the Modified Yale Preoperative Anxiety Scale (mYPAS).

Clinica Alemana de Santiago

Status: Enrolling

Conditions: Induction of Anesthesia; Technology Use; Anxiety After Surgery; Child Anxiety; Anxiety Preoperative; Anesthesia Care; Anxiety

Treatments: Device: Custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA); Other: Standard Parent-Present Induction (PPI)

Study type: Interventional

Funder types: Other

Identifiers

NCT07230743

ID 1483

Details and patient eligibility

About

This study is designed to evaluate the effect of technology as a distraction technique during anesthetic induction in children, starting from their arrival to the operating room. An interactive film will be displayed using a projector (BERT: Bedside Entertaining and Relaxation Tool) mounted on a whiteboard in front of the child's gurney. The primary outcome is perioperative anxiety, measured with the Modified Yale Preoperative Anxiety Scale (mYPAS).

Full description

This study is a randomized, controlled, open-label, parallel-assignment clinical trial designed to evaluate the effect of a non-pharmacologic technological intervention (projected video game) on perioperative anxiety in children during anesthetic induction.

Study type: Prospective, comparative clinical trial. Randomization: Simple randomization in a 1:1 ratio using an electronic sequence generated and administered in REDCap®.

Masking: Open-label (no blinding), as healthcare staff, caregivers, and patients can identify the presence or absence of the projected video game during induction. However, statistical analyses will be performed by investigators who did not take part in the intervention's implementation, in order to minimize bias.

Enrollment: 70 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing elective procedures under general anesthesia at Clinica Alemana
• Parent or caregiver presence for mask induction
• ASA I, II
• Ages 2-6 years of age
• Spanish speaking
• Parental consent/patient assent

Exclusion criteria

• Patient or parental does not consent
• ASA ≥ III
• Emergency surgery
• Intravenous induction of anesthesia
• Patient with a significant neurological condition or major developmental disability
• Severe visual or auditory defects
• Patients admitted using a crib as the mode of transport

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Standard Parent-Present Induction (PPI)

Active Comparator group

Description:

Participants in the Standard PPI group will undergo routine mask induction of anesthesia accompanied by a parent, with no additional structured distraction.

Treatment:

Other: Standard Parent-Present Induction (PPI)

Technology Intervention group

Experimental group

Description:

Participants in the Technology Intervention group will receive the same parent-present induction, with the addition of a custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA). The interactive audiovisual content is displayed on a large projection screen strategically placed at the foot of the operating table to ensure optimal visibility for the pediatric patient. Children will be instructed to watch and engage with the content as they enter the operating room and throughout the induction process.

Treatment:

Other: Standard Parent-Present Induction (PPI)

Device: Custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA)